To Assess the Efficacy of Collagen Supplement in Osteoarthritis

Launched by VEDIC LIFESCIENCES PVT. LTD. · Jul 8, 2020

Keywords

ClinConnect Summary

Osteoarthritis (OA) is a chronic progressive degenerative disease involving thinning of cartilage in movable joints that leads to friction between bones creating pain, stiffness, and abnormal movement. It is estimated to affect more than 20% of the population over the age of 60 years and is considered to be a major cause of morbidity, disability, and limitations on the quality of life. In India, studies have reported the prevalence of 22% to 39%, with OA being 2nd most common rheumatological disorder. , As global life expectancy increases, the prevalence of OA is expected to rise further ul...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male \& female aged ≥ 40 to ≤ 65 years suffering from knee joint pain for at least 3 months prior to screening.
• • BMI ≥ 18.5 and ≤ 29.9 kg/m2.
• • Non-vegetarians (Regardless of whether they eat chicken, fish, goat mutton, pork, beef or eggs).
• • Screening Visual Analogue (VAS) scores for knee joint pain ≥ 60 on a 100-point scale.
• • Radiographic evidence of grade II/III knee OA based on one of following criteria.
• • Participants willing to stop the restricted supplements and medications prior to inclusion and throughout the study period.
• • Participants willing to stop any home-based remedies or any other form of topical products intended for knee joint pain relief or any other reason for the entire study duration.
• • Willing to stop the use of study designated rescue medication 48 hours prior to all assessment visits.
• • Willing to abstain from food containing type II collagen only from cartilage, e.g. chicken, fish, beef, pork, etc. 48 hours prior to all assessment visits.
• Exclusion Criteria:
• • Prior or ongoing medical conditions (e.g. concomitant illness, psychiatric disorders, etc.), abnormal medical history or physical findings.
• • Participants with history of type II diabetes and uncontrolled hypertension.
• • Fasting Blood glucose \> 125 mg/dl
• • Systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
• • Radiographic evidence of Grade I or Grade IV OA based on the KL radiographic criteria for osteoarthritis.
• • Any history of trauma, fractures or surgery to the index joint.
• • Any planned surgery (diagnostic or therapeutic intervention) to the index joint during the participation in the study.
• • Participants with deformity of the knee joint.
• • Participants with a diagnosed condition which may involve or involves the index joint that includes but is not limited to known rheumatic or inflammatory conditions such as rheumatoid arthritis, osteomyelitis, osteoporosis, gout, and bone metastasis.
• • Other pathologic lesions on X-rays of the knee.
• • Current smokers or chronic alcoholics